RecruitingNot ApplicableNCT07027254

PETAL Trial: Impact of Gallium-68 Pentixafor PET-CT on Surgical Outcomes in Primary Aldosteronism

A Randomized Controlled Trial to Evaluate the Effect of Gallium-68 Pentixafor PET-CT on Surgical Outcomes in Patients With Primary Aldosteronism (The PETAL Trial)

Sponsor

Seoul National University Hospital

Enrollment

90 participants

Start Date

Jun 25, 2025

Study Type

INTERVENTIONAL

Conditions

Primary Aldosteronism Secondary Hypertension Aldosterone-Producing Adenoma Idiopathic Hyperaldosteronism Adrenalectomy

Summary

This study is a randomized controlled trial to assess the clinical utility of gallium-68 pentixafor PET/CT in the management of primary aldosteronism (PA). We aim to evaluate whether the addition of 68Ga-pentixafor PET/CT to standard adrenal venous sampling (AVS) improves surgical outcomes in patients with unilateral PA.

Eligibility

Min Age: 19 Years

Inclusion Criteria4

Age ≥19 years
Diagnosed with PA per 2016 Endocrine Society guidelines
Underwent adrenal CT
Signed informed consent

Exclusion Criteria6

Women who are pregnant, breastfeeding, or may become pregnant
Individuals who refuse to undergo surgery
Individuals for whom 68Ga-Pentixafor PET/CT, 11C-Metomidate PET/CT, or adrenal venous sampling (AVS) is not feasible or is refused due to underlying conditions
Individuals who refuse or experience adverse effects from dexamethasone premedication required for 11C-Metomidate PET/CT
Individuals with a history of abdominal open surgery or retroperitoneal surgery on the same side as the planned adrenalectomy
Any individual deemed unsuitable for the study at the discretion of the investigator

Interventions

DIAGNOSTIC_TEST68Ga-pentixafor PET/CT

Diagnostic PET/CT imaging using gallium-68 labeled pentixafor to assess adrenal CXCR4 expression in patients with primary aldosteronism. The imaging is performed prior to treatment allocation and used to assist lateralization of aldosterone production when combined with adrenal venous sampling (AVS).